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STA363 in the Treatment of Lumbar Disc Herniation

Primary Purpose

Lumbar Disc Herniation

Status
Recruiting
Phase
Phase 1
Locations
Poland
Study Type
Interventional
Intervention
Lactic Acid
Placebo
Sponsored by
Stayble Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lumbar Disc Herniation focused on measuring Lumbar radiculopathy

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Signed informed consent prior to any study-related procedures Patient has a single subligamentous posteriolateral lumbar disc herniation (protrusion or extrusion) of any lumbar disc below L1/L2 diagnosed by clinical symptoms and/or physical findings and confirmed by MRI Patient has symptoms and/or physical findings consistent with a unilateral radiculopathy affecting one nerve root (L2-L5) Patient has leg pain of the dermatome consistent with the nerve root affected by the herniation The herniated disc is 3 or lower on the Pfirrmann scale (grade 1-5) Patient has experienced symptoms of a herniated disc for at least 6 weeks prior to randomisation without sufficient relief with pain medications and other conservative therapies Ability to understand the written and verbal information about the study Male and female patients 18 years or older but 50 years or younger Women of childbearing potential eligible if using effective contraceptives Patient has a body mass index (BMI) of ≥18 to ≤35 kg/m2 Patients who meet all the following NRS selection criteria for radicular leg pain: Presence of at least 5 pain NRS assessments (entries) for 7 consecutive days NRS daily pain scores between 3-9 Not more than 2 NRS scores of "3" Exclusion criteria: Treatment with any investigational product within 3 months prior to the screening visit Patient has a sequestered lumbar disc herniation or transligamentous/ herniation confirmed by MRI Patient has a bulging disc Patient has experienced symptoms of lumbar disc herniation for more than 6 months Patient has 2 or more symptomatic lumbar disc herniations (presence of non-symptomatic herniations in addition to the symptomatic herniation is allowed) Patient has cauda equina syndrome Previous intradiscal therapeutic intervention of the index disc or has had any lumbar spine surgery Presence of lumbar spine disease and/or clinically significant deformity other than a lumbar disc herniation which, in the opinion of the investigator, will affect evaluation of safety and/or efficacy Untreated, ongoing active infection and/or discitis Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection. Evidence of prior lumbar vertebral body fracture or trauma. Spondylolisthesis or retrolisthesis grade 2 and above or spondylolysis at the index or adjacent level(s). Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index disc. Patients previously included in the study. Patients suffering from psychosomatic pain in the opinion of the Investigator. Patients requiring continuous treatment with warfarin or other anticoagulant therapy. Known alcohol and/or drug abuse. Pregnant or lactating females, or intention to become pregnant within the study period. Known allergy or intolerance to the contrast agent Omnipaque®. Known opioid allergy or intolerance. Any other condition that, in the opinion of the Investigator, precludes the patient from taking part in this study. Any specific contraindication for MRI such as claustrophobia, intracranial clips or pacemakers.

Sites / Locations

  • Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Ortopedii i RehabilitacjiRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

STA363

Arm Description

1.5 mL of Omnipaque mixed with water for injection

1.5 mL of STA363 (lactic acid, 120 mg/mL) mixed with Omnipaque

Outcomes

Primary Outcome Measures

Safety and tolerability
Safety and tolerability will be measured using the following outcomes: Incidence and nature of adverse events (AEs) Changes in physical examination findings blood pressure and heart rate 12-lead electrocardiogram Hematology and clinical chemistry Pain intensity at the injection site during and 15 minutes after injection (numerical rating scale; NRS). NRS is reported on a 0-10 scale where 0 represents "No pain" and 10 "Worst imaginable pain" Other aspects of intervertebral disc morphology (IVD) morphology from baseline (e.g., Modic changes)

Secondary Outcome Measures

Disc volume
Volume will be measured by MRI
Disc height
Height will be measured by MRI
Radicular leg pain
Leg pain will be reported by the patients using an NRS. (minimum value: 0; maximum value: 10) for 7 consecutive days. Lower scores means a better outcome.
Patient Global Impression of Change (PGIC)
PGIC will be reported by the patients using an electronic device
Disc intensity
The intensity of the disc will be measured using T2-weighted MRI

Full Information

First Posted
August 21, 2023
Last Updated
August 28, 2023
Sponsor
Stayble Therapeutics
Collaborators
Cromsource, Antaros Medical, VIEDOC
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1. Study Identification

Unique Protocol Identification Number
NCT06022263
Brief Title
STA363 in the Treatment of Lumbar Disc Herniation
Official Title
A Prospective, Randomised, Double-blinded, Placebo-controlled Study Investigating the Safety and Tolerability of STA363 in Patients With Radiculopathy Caused by Lumbar Disc Herniation
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 25, 2023 (Actual)
Primary Completion Date
May 31, 2024 (Anticipated)
Study Completion Date
August 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Stayble Therapeutics
Collaborators
Cromsource, Antaros Medical, VIEDOC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The goal of this clinical trial is to establish safety and tolerability of STA363 injected into a herniated intervertebral disc in patients with sciatica due to disc herniation. The main questions the trial aims to answer are: Is the treatment safe and tolerable? Does the volume of the disc and the herniation decrease? Is sciatica reduced? Participants will be given an injection into the herniated disc of either placebo or STA363 (one dose). Researchers will compare safety, tolerability, effects on disc and herniation volume and on symptoms between the group of patients injected with placebo and the group injected with STA363.
Detailed Description
The study will include 24 patients, recruited at 4 different sites, suffering from radiculopathy due to lumbar disc herniation (LDH). Patients will be screened for symptoms, disease history and magnetic resonance imaging (MRI) evidence of LDH. Baseline data (e.g. pain recording and MRI data) will be collected, and 1/3 of the patients will then be randomized to intradiscal injection with placebo (Omnipaque with water for injection, 1.5 mL) and 2/3 of the patients will be randomized to STA363 (lactic acid, 120 mg/mL with Omnipaque, 1.5 mL). The injections will be done using fluoroscopic guidance, and the patients will be treated with intravenous antibiotics and sedatives. The first follow-up will be done by phone 1 week after the treatment, while the other follow-ups will be physical visits at month 1, 3 and 6 at the site. In conjunction with the visits, the patient will record daily pain intensity (Numerical Rating Scale) for 7 days using an eDiary, and MRI will be performed. The primary completion time i 6 months with the primary objectives safety and tolerability. Important secondary objectives will be changes of disc volume and pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Disc Herniation
Keywords
Lumbar radiculopathy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
1.5 mL of Omnipaque mixed with water for injection
Arm Title
STA363
Arm Type
Experimental
Arm Description
1.5 mL of STA363 (lactic acid, 120 mg/mL) mixed with Omnipaque
Intervention Type
Drug
Intervention Name(s)
Lactic Acid
Other Intervention Name(s)
STA363
Intervention Description
180 mg of STA363 will be slowly injected into a symptom-generating herniated lumbar disc
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
1.5 mL of Omnipaque in water for injection will be slowly injected into a symptom-generating herniated lumbar disc
Primary Outcome Measure Information:
Title
Safety and tolerability
Description
Safety and tolerability will be measured using the following outcomes: Incidence and nature of adverse events (AEs) Changes in physical examination findings blood pressure and heart rate 12-lead electrocardiogram Hematology and clinical chemistry Pain intensity at the injection site during and 15 minutes after injection (numerical rating scale; NRS). NRS is reported on a 0-10 scale where 0 represents "No pain" and 10 "Worst imaginable pain" Other aspects of intervertebral disc morphology (IVD) morphology from baseline (e.g., Modic changes)
Time Frame
Baseline and 1 week and 1,3 and 6 months after intervention for all outcomes except changes in IVD morphology (time frame 1, 3 and 6 months after intervention)
Secondary Outcome Measure Information:
Title
Disc volume
Description
Volume will be measured by MRI
Time Frame
Baseline and 1,3 and 6 months after intervention
Title
Disc height
Description
Height will be measured by MRI
Time Frame
Baseline and 1,3 and 6 months after intervention
Title
Radicular leg pain
Description
Leg pain will be reported by the patients using an NRS. (minimum value: 0; maximum value: 10) for 7 consecutive days. Lower scores means a better outcome.
Time Frame
Baseline and 1 week and 1,3 and 6 months after intervention
Title
Patient Global Impression of Change (PGIC)
Description
PGIC will be reported by the patients using an electronic device
Time Frame
Baseline and 1 week and 1,3 and 6 months after intervention
Title
Disc intensity
Description
The intensity of the disc will be measured using T2-weighted MRI
Time Frame
Baseline and 1,3 and 6 months after intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Signed informed consent prior to any study-related procedures Patient has a single subligamentous posteriolateral lumbar disc herniation (protrusion or extrusion) of any lumbar disc below L1/L2 diagnosed by clinical symptoms and/or physical findings and confirmed by MRI Patient has symptoms and/or physical findings consistent with a unilateral radiculopathy affecting one nerve root (L2-L5) Patient has leg pain of the dermatome consistent with the nerve root affected by the herniation The herniated disc is 3 or lower on the Pfirrmann scale (grade 1-5) Patient has experienced symptoms of a herniated disc for at least 6 weeks prior to randomisation without sufficient relief with pain medications and other conservative therapies Ability to understand the written and verbal information about the study Male and female patients 18 years or older but 50 years or younger Women of childbearing potential eligible if using effective contraceptives Patient has a body mass index (BMI) of ≥18 to ≤35 kg/m2 Patients who meet all the following NRS selection criteria for radicular leg pain: Presence of at least 5 pain NRS assessments (entries) for 7 consecutive days NRS daily pain scores between 3-9 Not more than 2 NRS scores of "3" Exclusion criteria: Treatment with any investigational product within 3 months prior to the screening visit Patient has a sequestered lumbar disc herniation or transligamentous/ herniation confirmed by MRI Patient has a bulging disc Patient has experienced symptoms of lumbar disc herniation for more than 6 months Patient has 2 or more symptomatic lumbar disc herniations (presence of non-symptomatic herniations in addition to the symptomatic herniation is allowed) Patient has cauda equina syndrome Previous intradiscal therapeutic intervention of the index disc or has had any lumbar spine surgery Presence of lumbar spine disease and/or clinically significant deformity other than a lumbar disc herniation which, in the opinion of the investigator, will affect evaluation of safety and/or efficacy Untreated, ongoing active infection and/or discitis Current infection or prior history of spinal infection (e.g., discitis, septic arthritis, epidural abscess) or an active systemic infection. Evidence of prior lumbar vertebral body fracture or trauma. Spondylolisthesis or retrolisthesis grade 2 and above or spondylolysis at the index or adjacent level(s). Lumbar spondylitis or other undifferentiated spondyloarthropathy affecting the index disc. Patients previously included in the study. Patients suffering from psychosomatic pain in the opinion of the Investigator. Patients requiring continuous treatment with warfarin or other anticoagulant therapy. Known alcohol and/or drug abuse. Pregnant or lactating females, or intention to become pregnant within the study period. Known allergy or intolerance to the contrast agent Omnipaque®. Known opioid allergy or intolerance. Any other condition that, in the opinion of the Investigator, precludes the patient from taking part in this study. Any specific contraindication for MRI such as claustrophobia, intracranial clips or pacemakers.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tomasz Blicharski, MD, PhD
Phone
+48509678110
Email
blicharski@vp.pl
First Name & Middle Initial & Last Name or Official Title & Degree
Radoslaw Rola, MD, PhD
Phone
+48817144176
Email
rola.radoslaw@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jarkko Kalliomäki, MD, PhD
Organizational Affiliation
Stayble Therapeutics AB
Official's Role
Study Director
Facility Information:
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 4, Klinika Ortopedii i Rehabilitacji
City
Lublin
State/Province
Lubelskie
ZIP/Postal Code
20-002
Country
Poland
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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STA363 in the Treatment of Lumbar Disc Herniation

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